Records & Information Governance Specialist at Xeris… · Chicago

Overview

The Records & Information Governance Specialist will support the development, implementation, and maintenance of Xeris’s enterprise-wide records retention and information governance program. This role supports compliance with SEC requirements and FDA/GxP regulatory frameworks, including clinical, pharmacovigilance, manufacturing, and quality records. The position also contributes to privacy, data governance, and other information compliance initiatives across the Company.

Responsibilities

• Administer records retention and information governance program, including policies, procedures, and retention schedules.• Maintain retention schedules aligned with FDA (GxP), SEC, and other regulatory requirements applicable to a public biopharmaceutical company.• Partner with Legal, Quality, Regulatory, IT, and business stakeholders to ensure proper record classification, retention, and disposition.• Support management of GxP records, including clinical trial documentation, manufacturing batch records, pharmacovigilance data, and quality system records.• Monitor compliance and assist with audits, inspections, and internal reviews related to recordkeeping.• Execute defensible records disposition and deletion processes.• Administer legal hold processes including tracking, notices, and coordination with Legal and IT.• Assist with document preservation, collection, and organization for litigation, investigations, and regulatory inquiries.• Support privacy program efforts including data mapping, records inventories, and data subject request responses.• Assist with incident response tracking and documentation for data privacy events.• Support data governance initiatives including classification, lifecycle management, and Redundant, Obsolete, Trivial/Transitory, (ROT) data reduction.• Develop training materials and provide guidance to employees on records retention, privacy, and data governance requirements. Draft/disseminate employee communications accordingly.• Maintain audit-ready documentation of retention, privacy, and governance activities.

Qualifications

• Bachelor’s degree required.• 5+ years of relevant experience in records management, compliance, privacy, or information governance.• Familiarity with GxP and FDA-regulated recordkeeping requirements in the life sciences industry preferred.• Working knowledge of privacy laws (e.g., CCPA/CPRA, GDPR, etc.) preferred.• Experience with legal holds, eDiscovery, or compliance programs is a plus.• Strong organizational, communication, and analytical skills.• Ability to manage confidential information with discretion.• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Must be able to travel occasionally to off-site record retention facilities to conduct inventory-related activities. Activities may include standing for several hours at a time, and lifting, and carrying boxes. This is a hybrid position based in Xeris’ Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management’s discretion.

The level of the position will be determined based on the selected candidate’s qualifications and experience.

#LI-HYBRID

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

The anticipated base salary range for this position is $91,000 to $114,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.